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Executive/Senior Officer - Regulatory Affairs for Pharma MNC

By: Pharma Jobs | Views: 2273 | Date: 06-Jul-2013

FinOrion Pharma India Private limited, Subsidiary of Orion Corporation-FinlandOrion Corporation (www.orion.fi) is a pharmaceuticals company which develops, manufactures and markets pharmaceuticals and diagnostic tests worldwide. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. Orion has 3200 employees worldwide. With strong engagement in the promotion of healthcare, Orion has been building well-being for as many as 90 years. Our ambition in the fa

Executive/senior Officer - Regulatory Affairs, for Pharma MNC

by FinOrion Pharma India Private limited, Subsidiary of Orion Corporation-Finland in Mumbai Suburbs
Experience: 3 to 8 yrs.

Orion Pharma India Private limited

Job Description

  • To be responsible for preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/ amendments/annual reports as applicable documents in CTD and eCTD format according to EU and USA regulatory requirements.
  • To write documents as per regulatory requirements
  • To support local in-licensing
  • To collaborate with other departments/partners
  • To maintain lists/documents/records
  • To achieve his/her responsibilities within the agreed timescales

Salary:

Performance Bonus in addition to CTC

Industry:

Pharma / Biotech / Clinical Research

Functional Area:

Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:

Drug Regulatory Affairs/Documentation

Role:

Regulatory Affairs Manager

Keyskills:

Executive / senior Officer - Regulatory Affairs, for Pharma MNC, EU regulatory and ICH guidelines

Desired Candidate Profile

Education:

(UG - B.Pharma - Pharmacy) OR (PG - M.Pharma - Pharmacy) AND ( Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required)

  • Bachelors / Master degree in Pharmacy.
  • Required minimum 3 years work experience in international regulatory affairs from Pharma industry and experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities will be an added advantage.
  • Confirmed knowledge of EU requirements and ICH guidelines.
  • eCTD submissions experience will be an added advantage.
  • Task oriented with learning attitude.
  • Team work skills.
  • Fluency in oral and written English.
  • Confirmed skills of Microsoft Office is essential

Company Profile

FinOrion Pharma India Private limited, Subsidiary of Orion Corporation-Finland
Orion Corporation (www.orion.fi) is a pharmaceuticals company which develops, manufactures and markets pharmaceuticals and diagnostic tests worldwide. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. Orion has 3200 employees worldwide. With strong engagement in the promotion of healthcare, Orion has been building well-being for as many as 90 years. Our ambition in the far-sighted research activity is to introduce novel, innovative medicinal treatments for global markets.

Orion Corporation is strengthening its operations in India as part of its ambition to establish a global footprint and undertakes a recruitment-process of the following positions in its wholly owned subsidiary (FinOrion Pharma India Pvt Ltd) in Mumbai.

GD&PLM (Generics Development and Product Life-cycle Management) is part of Orion Pharma's R&D organisation and also part of Orion Pharma's Supply Chain process. It is responsible for evaluating and supporting the development of Orion's generics products, subcontracting and managing development of new products, compiling files and coordinating regulatory processes throughout the world of marketing authorisations as well as supporting production and quality control in their routine tasks, change control, product support, and marketing authorisation maintenance. GD&PLM also participates in the evaluation of generic products subject to potential in-licensing or contract manufacturing and their subsequent registration.

Contact Details
Recruiter Name:

Mr. Nitin Utekar

Contact Company:

Finorion Pharma India Private limited


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